Actively Recruiting
A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD-L1 Inhibitor, Carboplatin, and Etoposide as First-Line Treatment in Patients With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)
Led by China Medical University, China · Updated on 2026-01-28
36
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II, single-arm, single-center study evaluating Chidamide combined with a PD-L1 inhibitor, carboplatin, and etoposide as first-line therapy in extensive-stage small-cell lung cancer (ES-SCLC) patients. The primary objective is to assess Progression-Free Survival (PFS) per RECIST v1.1. Secondary objectives include Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (OS), and safety. Approximately 36 participants will receive induction therapy (Chidamide + chemotherapy + PD-L1 inhibitor) for 4 cycles, followed by Chidamide maintenance until progression or unacceptable toxicity.
CONDITIONS
Official Title
A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD-L1 Inhibitor, Carboplatin, and Etoposide as First-Line Treatment in Patients With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Histologically confirmed extensive-stage small-cell lung cancer unsuitable for local radical therapy
- No prior systemic therapy for extensive-stage small-cell lung cancer
- ECOG performance status of 0 or 1
- At least one measurable lesion according to RECIST v1.1
- Expected survival of at least 3 months
- Adequate blood, liver, kidney, and heart function
- Use of effective contraception from consent until 180 days after last dose
- For active hepatitis B infection: HBV DNA less than 2000 IU/mL within 28 days before treatment and stable antiviral therapy
- Recovery from prior therapy toxicities to grade 1 or less, except for hair loss
- Signed informed consent form
You will not qualify if you...
- Conditions that significantly affect oral drug absorption
- Previous treatment with HDAC inhibitors or immune checkpoint inhibitors
- Known allergy to any component of the study drugs
- Other cancers within the past 5 years except certain cured cancers
- Participation in another clinical trial within 4 weeks before study entry
- Immunodeficiency, HIV positive status, or history of organ transplant
- Uncontrolled heart disease or QTc interval longer than 450 ms
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Severe other medical conditions considered unsafe by the investigator
- History of neurological or psychiatric disorders
- Any condition making the patient unsuitable for the study as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
Y
Yunpeng Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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